FDA: Page 97
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Patient-matching tools nowhere near perfect, Pew says
A report recommends clarifying government funding restrictions for unique identifiers, agreeing on standardized demographics, assessing privacy ramifications and researching referential matching using third-party data.
By Rebecca Pifer Parduhn • Oct. 2, 2018 -
Stryker settles foreign corrupt practice charges, makes small acquisition
The company will pay $7.8 million to settle with the Justice Department. Separately, the medical device maker said it would acquire HyperBranch Medical Technology.
By Susan Kelly • Oct. 2, 2018 -
Explore the Trendlineâž”
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
FDA, ECRI, device group keep up drumbeat on cybersecurity risks
The agency is launching a cybersecurity playbook for healthcare providers and said it will publish a "significant update" to its 2014 premarket guidance.
By Susan Kelly • Oct. 2, 2018 -
FDA starts 510(k) pilot in bid to shorten reviews
The effort will test the expanded criteria for Special 510(k) Program filings.
By Nick Paul Taylor • Oct. 2, 2018 -
5 themes from The MedTech Conference
Mergers and acquisitions, digital health, FDA pilot programs and Netflix's The Bleeding Edge were among the hot topics in Philadelphia.
By David Lim , Kim Dixon • Oct. 1, 2018 -
FDA exploring potential for IMDRF Medical Device Single Review Program
The idea is for the marketing authorization for a medical device by one country to be relied on in part or in whole by other participating jurisdictions, according to FDA device chief Jeff Shuren.
By David Lim • Oct. 1, 2018 -
FDA finds fault with some insulin pen use directions
The agency is asking manufacturers to review their directions for use and training materials and consider adding a label warning about the need to remove both the outer and inner needle covers.
By Susan Kelly • Oct. 1, 2018 -
FDA clears NGS test to detect residual blood cancer cells
Adaptive Biotechnologies' assay detects and monitors minimal residual disease in multiple myeloma and B-cell acute lymphoblastic leukemia patients.
By Susan Kelly • Oct. 1, 2018 -
FDA floats changes to Special 510(k) program
The update will expand use of the program to a wider range of device modifications.
By Nick Paul Taylor • Sept. 28, 2018 -
New IMDRF committee to tackle cybersecurity threats
The FDA device chief laid out takeaways from the group's Beijing meeting.
By Kim Dixon • Sept. 27, 2018 -
Shuren: Funds needed to launch FDA Center of Excellence for Digital Health
The device center head's warning comes as Commissioner Scott Gottlieb stresses the importance that Congress keep investing in the FDA.
By David Lim • Sept. 27, 2018 -
FDA reopens comments on decade-old stent guidance
It comes days after physicians writing in The Lancet used data from a head-to-head comparison of Medtronic's Resolute Onyx and Biotronik's ultra-thin-strut stent Orsiro to highlight the limitations of noninferiority clinical trial designs.
By Nick Paul Taylor • Sept. 27, 2018 -
Jacob Bell/MedTech Dive
FDA reclassifies female condoms to reduce regulatory burden
The products will be categorized as Class II devices eligible for the 510(k) pathway.
By Nick Paul Taylor • Sept. 27, 2018 -
FDA expands use of Baxter bone graft to spinal fusion
Rivals Medtronic, Johnson & Johnson, Stryker and Zimmer are all competing for the bone graft substitute piece of the advanced surgery market.
By Nick Paul Taylor • Sept. 27, 2018 -
FDA
FDA's Patel touts promise of software precertification program
Despite concern from the Clinical Decision Support Coalition​ that FDA may not have the legal ability to launch the pilot, the agency says it will work through its current authorities.
By David Lim • Sept. 26, 2018 -
Premier gets FDA clearance for saliva-based opioid tests
The regulatory nod expands use of OralTox to oxycodone and methadone.
By Nick Paul Taylor • Sept. 26, 2018 -
Industry lobbying CMS for speedy Medicare coverage of breakthrough devices
The Center for Medicare and Medicaid Innovation may launch a demonstration project to examine how to balance speeding devices to Medicare patients with the cost implications.
By David Lim • Sept. 25, 2018 -
Medtech companies race to adapt amid vertical integration, new tech threats
The industry is increasingly sharing the risk with payers as a way to prove product value.
By Kim Dixon • Sept. 25, 2018 -
AdvaMed chief: Success in warding off tariffs, but impact rising
While medical devices aren't explicitly on the most recent list of tariffs, the list likely includes component parts used by members of the industry.
By Kim Dixon • Sept. 25, 2018 -
FDA gives final guidance on device benefits, risks in 510(k) submissions
The recommendations will help in determining substantial equivalence for devices with different characteristics that don't raise new questions of safety and effectiveness, the FDA said.
By Susan Kelly • Sept. 25, 2018 -
FDA approves Cook PAD stent as competition heats up
The approval comes shortly after Boston Scientific received clearance to sell a rival device.
By Nick Paul Taylor • Sept. 25, 2018 -
EY warns stagnant R&D, data use threatens medtech growth
Medtech R&D investment of $15.9 billion remained "relatively unchanged" in 2017 — roughly $1 billion less than the $16.4 billion companies gave back to investors through share buybacks and dividends.
By David Lim • Sept. 24, 2018 -
ACLA lab payment lawsuit dismissed by judge
The clinical lab lobby had argued HHS did not collect data from a wide enough range of laboratories when establishing Medicare payment rates.
By David Lim • Sept. 24, 2018 -
OIG advisory opinion cracks door open for device bundle warranties
The guidance comes as HHS awaits feedback on ways to improve the Anti Kickback Statute to ease obstacles to coordinated or value-based care.
By David Lim • Sept. 21, 2018 -
FDA says Florence unlikely to cause critical device shortages
The agency is closely monitoring 10 sites that make critically important devices and biological products.
By Nick Paul Taylor • Sept. 20, 2018
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